CN105073160A

CN105073160A - Infusion device with layered structure having durable and disposable components

Info

Publication number: CN105073160A
Application number: CN201480018250.6A
Authority: CN
Inventors: E.洛佩兹
Original assignee: Animas LLC
Current assignee: Animas LLC
Priority date: 2013-03-27
Filing date: 2014-03-10
Publication date: 2015-11-18
Also published as: AU2019201034A1; US20140296784A1; TW201505678A; EP2978469A1; WO2014159207A1; JP2016517717A; AU2014241125A1; CA2908264A1; KR20150135483A; BR112015024464A2; RU2015145962A

Abstract

The invention provides an infusion device with layered structure having durable and disposable components. The infusion device with a durable portion and a disposable portion, comprises a reservoir that holds a liquid medicament, a pump that displaces the liquid medicament from the reservoir to the patient, at least one valve that conducts the displaced medicament from the reservoir, and a fluid conduit that conducts the medicament from the reservoir, to the pump, and to the patient. The device includes a layered structure that defines the reservoir and fluid conduit.

Description

Comprise the injection device of the hierarchy with durable and disposable unit

The cross reference of related application

This application claims the priority of the U.S. Provisional Application 61/805,742 submitted on March 27th, 2013, the disclosure of this application is incorporated herein by reference in full.

Technical field

The present invention relates to injection device, more specifically, relate to such device, described device allows fluid medicine easily and safely by patient's self-administration.

Background technology

Verified, the strict control of sending the insulin of type i diabetes and type ii diabetes improves quality of life and the holistic health of patient.Insulin send always with subcutaneous injection protamine zine insulin to meet patient's fundamental need and subcutaneous injection short-acting insulin to compensate meals and snacks.Recently, the development of insulin outside injection electric pump has allowed to continue to inject Semilente Insulin to maintain supplementary dosage or the tablet of fundamental need and meals and snacks.Verified, these injected systems improve the control to blood glucose levels.But there is volume greatly, costly and the shortcoming of complexity in these systems.Such as, these pumps electronically control, and must be programmed to basal insulin and the pre-meal insulin of supplying aequum.Which prevent many patients and accept this technology being better than standard subcutaneous injections.

Therefore, there are the needs to not needing important programming or technical capability can meet basis and the portable insulinize of needs before the meal in this area.Preferably, this type for the treatment of will be simple by use, and implement with the injection device not needing the mechanical system of battery etc. to drive.If described injection device directly can be attached to health and programme to delivery rate without any need for electronic device also will be preferred.Preferably, insulin with the technology being similar to prior art by little and the pipe of thin-walled or intubate enter subcutaneous tissue through skin and send.

Such device although the idea of this type of simple insulin delivery apparatus is noticeable, many obstacles must be overcome before can be realized.A problem is insulin supply.Patient must carry such device to provide the amount of the insulin of one period of set time (such as, three days) internal therapy widely different.This is a kind of size and is not suitable for a proprietary environment.Further, such device must dress safety, and not by the impact of possible unexpected dosage.Further, such device reliably must send the medicine of precise control amount.Although these equipment preferably include above all feature structures, if to make, device is namely discardable after a procedure will be more preferably the expense manufacturing such device by enough economical.As will be described later, apparatus and method as herein described solve these and other problems.

Accompanying drawing explanation

It is believed that it is that multiple feature structures of novelty of the present invention are specifically shown in appended claims.The present invention and other feature structure and advantage thereof are by getting the best understanding with reference to following description by reference to the accompanying drawings, and in some figures of accompanying drawing, identical reference accompanying drawing indicates identical element, and wherein:

Fig. 1 is the perspective view of the first injection device embodying some aspect of the present invention;

Fig. 2 is the valve of the device of Fig. 1 and the schematic diagram of pump;

Fig. 3 is the decomposition diagram of the device of Fig. 1;

Fig. 4 illustrates that the pump of device is directly coupled to the perspective section view of the device of Fig. 1 of actuator button;

Fig. 5 is the perspective section view of the device of Fig. 1 that valve before delivering drugs dosage and valve and actuated linkage are shown;

Fig. 6 is the profile of magnification ratio, and the actuated linkage before delivering drugs dosage is shown;

Fig. 7 is the profile similar with Fig. 6, and the actuated linkage during delivering drugs dosage is shown;

Fig. 8 is another profile similar with Fig. 5, and the actuated linkage after just delivering drugs dosage is shown;

Fig. 9 is the perspective view of another injection device embodying many aspects of the present invention;

Figure 10 is that drug dose is sent and with the schematic diagram of the valve of the device of the Fig. 9 between medicine filling pump and pump;

Figure 11 is the valve of the device of Fig. 9 between drug dose delivery period and the schematic diagram of pump;

Figure 12 is the decomposition diagram of the device of Fig. 9;

Figure 13 is the perspective view of parts of the device of Fig. 9;

Figure 14 is the perspective profilograph of Fig. 9 device, and the exploded view of the cannula assembly used wherein is shown;

Figure 15 is the perspective profilograph of Fig. 9 device being similar to Figure 14, and the cannula assembly relevant to described device operability is shown;

Figure 16 illustrates the sectional plain-view drawing of filling the valve constitution of the device of period Fig. 9 at pump;

Figure 17 is the sectional plain-view drawing of the valve constitution of the device illustrated at drug delivery period Fig. 9;

Figure 18 is the perspective section view of magnification ratio, and the actuated linkage of the device of Fig. 9 before drug dose is sent is shown;

Figure 19 is the profile being similar to Figure 18, and the actuated linkage of the device of Fig. 9 between drug dose delivery period is shown;

Figure 20 is the profile being similar to Figure 18, and the actuated linkage of the device of Fig. 9 after drug dose is sent is shown;

Figure 21 is the perspective section view of another magnification ratio, shows the operation of actuated linkage;

Figure 22 is the perspective section view of another magnification ratio being similar to Figure 21, shows the operation of actuated linkage;

Figure 23 is another profile, illustrates that sending dosage last between period of energization at normal drug locks and device pump;

Figure 24 is the profile being similar to Figure 23, and dosage locking last after normal drug is sent and device pump are shown;

Figure 25 is the profile being similar to Figure 23, illustrates that being adjusted in the end normal drug sends the last dosage locking of forbidding actuator when rear device pump returns;

Figure 26 is the profile being similar to Figure 23, and the last dosage locking of forbidding actuator when final drug delivery is shown;

Figure 27 is the profile of another magnification ratio, and device pump and the filling mouth got clogged between drug delivery period of energization are shown; And

Figure 28 is another profile being similar to Figure 22, device pump is shown and is locked in the filling mouth of blocked state by final dose.

Figure 29 has profile that the is durable and one embodiment of the invention of disposable unit.

Figure 30 is the exploded view of an embodiment of multilamellar disposable unit of the present invention.

Figure 31 is the perspective view of the disposable unit of the Figure 30 comprising optional feature in fluid passage.

Figure 32 is the perspective view of the disposable unit of the Figure 31 comprising optional feature in fluid passage.

Figure 33 A and 33B is the perspective view of disposable unit shown in Figure 32, and the cap in exploded view in Figure 33 A is shown.

Figure 34 is the perspective view of disposable unit and durable components.

Figure 35 A and 35B is the perspective view of the partial cross sectional of an embodiment of medical injected system durable components.

Figure 36 has perspective view that is durable and the medical injected system of disposable unit.

Detailed description of the invention

Referring now to Fig. 1, it is the perspective view of the first injection device embodying some aspect of the present invention.Device 10 generally includes shell 12, base 14, first actuation control button 16 and the second actuation control button 18.

As will be described later, shell 12 is formed by the multiple device layers pieced together.Each layer defines multiple parts of device, such as, and reservoir, fluid conduit systems, pump chamber and valve chamber etc.According to many aspects of the present invention, this device structural form allows to manufacture economy to a certain extent and makes device with rear discardable.

Base 14 preferably includes the adhesive coatings allowing device to be adhered to patient skin.Adhesive coatings can be coated with peelable covering at first, and it can be peeled off from base 14 when patient attempts erecting device 10.This type of layout is well-known in the art.

Device 10 can coordinate with the cannula assembly installed in the past.But imagining many aspects of the present invention herein can realize in a kind of device, and this device alternatively first can adhere to patient skin, is then installing intubate afterwards.

Actuation button 16 and 18 is positioned at the opposite side of device 10, and directly on opposite each other.This makes to press the button when patient wants to take the fluid medicine comprised in potion device 10 convenient simultaneously.This layout is also applied with substantially equal and contrary power in case locking apparatus moves and comes off from patient possibly with it to device during dose delivery.As further described below, will pressed the button and there is specific advantages simultaneously.More specifically, actuation button 16 can be used as control valve device, it sets up first fluid passage to support that pump is filled between device reservoir and device pump when being in primary importance as shown in the figure, then, its be in second or depressed position time set up second fluid passage and be delivered to patient with acceptable dose between device pump and device outlet or intubate.As will as further described below, only when setting up second fluid passage by the first actuation control button 16, the connector controlled between actuation button 16 and 18 just allows by actuation control button 18 actuating device pump.Therefore, the first actuation control button 16 can be regarded as safety control.

Referring now to Fig. 2, it is the valve of device 10 and the schematic diagram of pump of Fig. 1.Can as shown in Figure 2, device 10 also comprises fills mouth 20, reservoir 22, pump 24 and intubate 30.Described device also comprises the first valve 32 and the second valve 34.Fluid conduit systems 40 provides fluid to connect between filling mouth 20 and reservoir 22, fluid conduit systems 42 provides fluid to connect between reservoir 22 and the first valve 32, fluid conduit systems 44 provides fluid to connect between the first valve 32 and pump 24, fluid conduit systems 46 provides fluid to connect between pump 24 and the second valve 34, and fluid conduit systems 48 provides fluid to connect between the second valve 34 and device outlet 50.Outlet 50 is arranged to communicate with intubate 30.

Also it is pointed out that actuation button 16 and 18 is loaded by spring 36 and 38 spring.Described spring is set to after dosage is taken, make actuation button be back to primary importance.

The pump 24 of device 10 comprises piston pump.Pump 24 comprises pump piston 26 and pump chamber 28.According to the present embodiment, actuation control button 18 is directly coupled to and is the extension of pump piston 26.

With further reference to Fig. 2, described device comprises the first connector 52 and the second connector 54 in addition.First connector is the toggle joint type connector between the first valve 32 and the second valve 34.Such layout is in order to ensure the second valve 34 until the first valve 32 just opens after cutting out.Second connector 54 is between the first actuation button 16 and the second actuation button 18.Such layout is in order to ensure pump until the first actuation button 16 is closed the first valve and opened the just pump suction of the second valve.

Further, the second valve 34 is relief valve, and it is closed more tightly in response to fluid conduit systems 46 fluid pressure increases.Which ensure that fluid medicine can not cannot be born (such as) reservoir is not intended to execute stressed patient and surprisingly take.In such as this type of application, reservoir is formed unrare by flexible material.Even now has its advantage, the danger that may surprisingly be extruded when also also can occur that reservoir is worn.Because the second valve only cuts out under such conditions more tightly, ensure that reservoir accidental pressure increases and fluid medicine can not be caused to flow to intubate.

During operation, first reservoir is filled the medicine of desired level by filling mouth 20.In this state, valve 32 and 34 will as shown in the figure.First valve 32 will be opened, and the second valve 34 will cut out.This allows piston chamber 28 to be filled after reservoir is filled.Then intubate 30 can be installed after erecting device 10.In this state, valve 32 and 34 will still as shown in the figure.First valve 32 will be opened, and the second valve 34 will cut out.This allows pump chamber 28, when piston 24 is back to its primary importance after each applying dosage, is filled by the first fluid passage comprising conduit 42 and 44.

When patient wants to take dose medicine, press actuation button simultaneously.According to many aspects of the present invention, connector 52 causes the first valve 32 to be closed, and causes thereafter the second valve 34 to be opened.Meanwhile, the second connector 54 stops actuated pump 24 until the first valve 32 is cut out by the first actuation button 16 and the second valve 34 is opened by the first actuation button 16.Now set up from the second fluid passage of pump 24 to intubate 30 by fluid conduit systems 46 and 48 and outlet 50.Then medicine is taken by patient by intubate 30.

Once drug dose is taken, piston 24 and actuation button thus 18 are back to its initial position under the spring pressure of spring 38.During piston advances back its primary importance, the fluid medicine of the specified rate sent for subsequent dose is pumped to pump chamber 28 from reservoir, thinks that device carries out its subsequent dose and sends ready.

Referring now to Fig. 3, it is the decomposition diagram of the device of Fig. 1.Fig. 3 illustrates multiple element portion of this device.Critical piece part comprises aforesaid device layers, and this device layers comprises bottom 60, reservoir film or intermediate layer 62 and acrosome layer 64.Bottom is the integrative-structure of rigidity substantially, which defines the first reservoir part 66, pump chamber 28 and the first valve and the second valve valve cage 68 and 70 separately.Bottom 60 can (such as) be formed by plastics.Reservoir rete 62 is contained on reservoir part 66, forms reservoir 22 (Fig. 2).Valve seat construction 72 is contained on valve cage 68 and 70, forms the first valve 32 and the second valve 34 (Fig. 2) respectively.Rocking bar 74 is positioned on valve seat construction 72, to open or close described valve as mentioned below.Pump actuation button 18 carries the pump piston be contained in pump chamber 28.Pump actuation button 18 also carries the cam barrel 76 wherein with lock tube 78, and wherein lock tube 78 defines a part (Fig. 2) for the second connector 54.After each dose delivery, actuation button 18 is back to its primary importance by spring 38.

The valve timing cam 80 of the first actuation control button carrying shake rocking bar 72.The cam pin 84 that button 16 also carries cam barrel 82 and is contained in cam barrel 82.After each dose delivery, actuation button 16 is back to its primary importance by spring 36.The top of acrosome layer 64 forming apparatus shell.It has held the plane cap 86 that part is formed in the fluid passage 85 on top layer 64.Finally, provide pin 88, described pin provides the fluid exported from intubate (not shown) to device 10 to couple.

Fig. 4 illustrates the perspective section view of the device of Fig. 1.More specifically, this accompanying drawing illustrates the details of the piston pump 24 in device 10.Can find out, the piston 26 of piston pump 24 is contained in pump chamber 28, and this pump chamber is formed in the bottom 60 of device herein.Also can find out, piston 26 is the extension of actuation button 18.O shape ring 90 provides the sealing between pump chamber 28 and piston 26.After each dose delivery, actuation button 18 is back to primary importance shown in it by spring 38.

Fig. 5 is the perspective section view of the device of Fig. 1 that valve 32 and 34 and valve and actuated linkage before delivering drugs dosage are shown.First these valves will be described.First, can point out, valve seat construction 72 is contained in valve cage 68 and 70.Valve seat construction 72 comprises the valve seat 92 and 94 be contained in respectively in valve cage 68 and 70.Each in valve seat 92 and 94 has widened section 96 and 98 respectively, causes these closely to sit in response to the fluid pressure gone up increases in downward direction and puts in sleeve 68 and 70.As previously mentioned, this prevent the potential impact of the unexpected drug delivery that the external pressure that puts on device reservoir causes.

Rocking bar 74 opens and closes valve 32 and 34.The control of the timing cam 80 that it carries by the first actuation control button 16.When control knob 16 transverse shifting, cam 80 causes rocking bar 74 pivotable and applies pressure to one or the other in valve seat 92 or 94.Camsurface appearance on rocking bar 74 and cam 80 guarantees valve 34 until valve 32 cuts out just can open.Thus, cam 80 and rocking bar 74 form the first connector 52 shown in Fig. 2.

Although cam 80 and rocking bar 74 driven valve 32 and 34 under the timing that the first connector 52 provides controls, when pump can move fluid medicine to device outlet and intubate from pump chamber 28, the second connector 54 controls.Fig. 5-8 illustrates the details of the second connector.

Can find out from Fig. 5 and 6, the second connector comprises cam barrel 76, lock tube 78, external cam cylinder 82 and cam pin 84.Cam barrel and the second actuation control button 18 integral, and external cam cylinder 82 and the first actuation control button integral.Second connector 54 also comprises lock core 100.Both is positioned in the hole 102 in device bottom 60.

When actuation button is in its primary importance as shown in Figure 6, the end of the end abutment lock core 100 of lock tube 78.Lock core comprises lock ear 104.When needs dose delivery, press the button 16 and 18 simultaneously and cause external cam cylinder 82 first to against lock core 100 to slide, then cam barrel 76 againsts lock tube 78 and slides.External cam cylinder 82 against lock core 100 slide cause first valve close and the second valve open.When this step completes, cam barrel 76 allows to against lock tube 78 and slides to cause piston 26 to move through pump chamber 28.This move fluid medicine in pump chamber 28 with by drug delivery to intubate 30 and patient.

Fig. 7 illustrates the mode that external cam cylinder 82 slides along lock core 100.Can first point out, cam pin 84 has reduced part, and this defines annular space 106 between pin 84 and lock core 100.External cam cylinder 82 engages the pin being positioned at flange 108 place of pin 84.This joint will cause pin 84 to move with external cam cylinder 82.Press the lock ear 104 that the first actuation button 16 will cause external cam cylinder 82 to engage lock core 100, meanwhile, the end of pin 84 moves in lock tube 78.Finally, pressed enough low by external cam cylinder 82 lock ear 104 shifts out the lock core 100 forced down during in the end of pin 84, enter gap 106 to allow lock ear 104.This is with fastening sound, and perceptual image occurs suddenly.External cam cylinder 82 can against now lock core 100 and freely to slide its complete travel distance.Valve 32 cuts out now, and valve 34 is opened.

The snap action of actuation button 16 and 18 provides to patient the front that potion medicine sent and confirms.In addition, because this snap action only occurs when pump actuation button 18 completes its whole stroke, therefore, patient also will know and sent all dosage.

External cam cylinder 82 has completed after it againsts advancing of lock core 100, and lock ear 104 will fully move in gap 106 to allow cam barrel 76 shift out the end of lock core 100 and against lock tube 78 and slide.Now the situation of the second connector 54 as shown in Figure 8.As previously mentioned, when cam barrel 76 against lock tube 78 slide time, pump 24 activated with by drug delivery to patient.

Referring now to Fig. 9, it is the perspective view of another injection device embodying many aspects of the present invention.Device 210 mainly comprises shell 212, base 214, first actuation control button 216 and the second actuation control button 218.

Shell 212 is formed by the multiple device layers pieced together.Each layer defines multiple parts of device, such as reservoir, fluid conduit systems, pump and valve chamber etc.According to many aspects of the present invention, this device structural form allows to manufacture economy to a certain extent and makes device with rear discardable.

Base 214 preferably includes the adhesive coatings allowing device to be adhered to patient skin.Adhesive coatings can be coated with peelable covering at first, and it can be peeled off from base 214 when patient attempts erecting device 210.This type of layout is well-known in the art.

As described below equally, device 210 can mate with the cannula assembly installed in the past.But imagining many aspects of the present invention herein can realize in a kind of device, and this device alternatively first can adhere to patient skin, is then installing intubate afterwards.

As in the previous embodiments, actuation button 216 and 218 is positioned at the opposite side of device 210, and directly on opposite each other.This also makes to press the button when patient wants to take the fluid medicine comprised in potion device 210 convenient simultaneously.This layout is also applied with substantially equal and contrary power in case locking apparatus moves and comes off from patient possibly with it to device during dose delivery.As further described below, will pressed the button and there is specific advantages simultaneously.More specifically, actuation button 216 can be used as control valve device, it sets up first fluid passage to support that pump is filled between device reservoir and device pump when being in as directed primary importance, then, its be in second or depressed position time set up second fluid passage and be delivered to patient with acceptable dose between device pump and device outlet or intubate.As will as further described below, only when setting up second fluid passage by the first actuation control button 216, the connector controlled between actuation button 216 and 218 just allows by actuation control button 218 actuating device pump.Therefore, the first actuation control button 216 can be regarded as safety control.

Continue see Fig. 9, can it is further noted that, device 210 also comprises tactile indicators 260, and it represents the fluid medicine amount that each actuated pump 224 timer is sent.Tactile indicators is carried by pump actuation button 218 and adopts the feature structure of multiple obvious projection or the form of protrusion 262 and 264.Alternatively, tactile indicators can adopt the form of one or more obvious ledge.Each protrusion 262 and 264 may correspond in single pharmaceutical units.Therefore, in this embodiment, protrusion 262 and 264 indicates each actuated pump timer to send the medicine of two units.

The tactile indicators 260 be carried on pump actuation control button 218 provides very important feature structure and advantage.As will be described later, pump actuation button 218 has the integral extension of the piston 226 of formation (shown in Figure 10 as mentioned below) piston pump 224.Also will find out, piston chamber 228 is formed in the parts of device, and these parts can be used on sends two units with in the device of external dose.These parts may all belong to common for all such devices, because it can have fixed piston room length, and dosage is determined by the range of pump piston 226.Each piston range is indispensable for this part, and dosage corresponding given respectively.Then, corresponding tactile indicators can be provided to each pump actuation button of given dose.Therefore, if tactile indicators indicates the dosage of two units, such as, tactile indicators ensure that that is exactly the medication amount of being sent by particular pump button.Further, this layout is also favourable from manufacture angle, because the actuation button of the large dingus of various dosage can not be obscured each other.

Referring now to Figure 10 and 11, Figure 10 and 11, be that drug dose is filled (Figure 10) and drug dose and sent the valve of the device of the Fig. 9 between (Figure 11) and the schematic diagram of pump.As Figure 10 and 11 visible, device 210 also comprises reservoir 222, pump 224 and intubate 230.This device also comprises reversal valve 231, thus forms the first valve 232 limited by O shape ring 233 and 235 and the second valve 234 limited by O shape ring 237 and 239.Although use O shape ring to form sealing in this article, without departing from the present invention, the valve arrangement of other types can preferably adopt the seal form being different from O shape ring.Fluid conduit systems 240 extends between valve 232 and 234.The fluid that fluid conduit systems 242 provides between reservoir 222 and reversal valve 231 connects, and the fluid that fluid conduit systems 244 provides between reversal valve 231 and pump 224 connects.The fluid that other fluid conduit systems 246 provides between reversal valve 231 and device outlet 250 connects.The outlet 250 of the form of needle tubing is arranged to be communicated with intubate 230.

Also may it should be noted that actuation button 216 and 218 is loaded by spring 236 and 238 spring.Described spring is set to after dosage is taken, make actuation button be back to primary importance.

The pump 224 of device 210 comprises piston pump.Pump 224 comprises pump piston 226 and pump chamber 228.According to the present embodiment, actuation control button 218 is directly coupled to and is the extension of pump piston 226.

With further reference to Figure 10 and 11, described device comprises the first connector 252 and the second connector 254 in addition.First connector is formed by the bar 241 that shuttles back and forth of the first valve 232 and the second valve 234.First connector is arranged by valve 232 and 234 is separated a segment distance, to guarantee the second valve 234 until the first valve 232 just opens after cutting out.Second connector 254 is between the first actuation button 216 and the second actuation button 218.Such layout is in order to ensure pump 224 until the first actuation button 216 is closed the first valve 232 and opened the just pump suction of the second valve 234.

Further, the second valve 234 is relief valve, which ensure that fluid medicine can not cannot be born and be not intended to execute stressed patient to (such as) reservoir surprisingly to take.In such as this type of application, reservoir is formed unrare by flexible material.Even now has its advantage, the danger that may surprisingly be extruded when also also can occur that reservoir is worn.Because the second valve 234, ensure that unexpected extruding reservoir can not cause fluid medicine to flow to intubate.

In operation, when actuation button 218 is back to primary importance after just having sent drug dose, first fill pump chamber 228.In this state, reversal valve 231 is set so that the first valve 232 will open (reservoir 222 is communicated with fluid conduit systems 240) and the second valve 234 will cut out (conduit 246 with fluid conduit systems 240 isolate).Which establishes through the first fluid passage of conduit 242,240 and 244 from reservoir 222 to pump 224, allow piston chamber 228 to be filled by reservoir when actuation button is back to its primary importance under the impact of spring 238.

When patient wants to take another dose drug, press actuation button simultaneously.According to many aspects of the present invention, connector 252 causes the first valve 232 to be closed, and causes thereafter the second valve 234 to be opened.Meanwhile, the second connector 254 stops actuated pump 224 until the first valve 332 is cut out by the first actuation button 216 and the second valve 334 is opened by the first actuation button 216.Now set up from the second fluid passage of pump 224 to intubate 30 by fluid conduit systems 244,240 and 246 and outlet 250.Then medicine is taken by patient by intubate 30.

Once drug dose is taken, piston 224 and actuation button thus 218 are back to its initial position under the spring pressure of spring 238.During piston marches to its primary importance, the fluid medicine of the specified rate sent for subsequent dose is pumped to pump chamber 228 from reservoir, as mentioned above, thinks that device carries out its subsequent dose and sends ready.

Referring now to Figure 12, it is the decomposition diagram of the device being Fig. 9.It illustrates multiple element portion of device 210.The same with the device 10 of Fig. 1, device 210 is with device layers structure, and this device layers comprises bottom 280, intermediate layer 282 and acrosome layer 284.

Also can as shown in figure 13, bottom 280 is the integrative-structure of rigidity substantially, which defines the valve chamber 290 of the first reservoir part 286, pump chamber 228 and the first valve 232 and the second valve 234.Bottom 280 can (such as) be formed by plastics.

Valve chamber 290 is positioned to receive and is carried by the first actuation button 216 and to shuttle back and forth bar 241 from the valve that the first actuation button 216 extends.O shape ring 233,235,237 and 239 is arranged to seat and puts and shuttling back and forth on bar 241 to form the first valve 232 and the second valve 234 (Figure 10) respectively.Actuation button 216 also carries the Part I 292 of the second connector 254 (Figure 10).Second connector is contained in the hole 295 of suitable constructions, and this hole is formed in bottom 280, will hereafter be described.

Pump actuation button 218 carries the Part II 294 of pump piston 226 and the second connector 254.Pump piston 226 is positioned to receive in pump chamber 228, and the Part II 294 of the second connector 254 is positioned to receive in hole 295 to interact with Part I 292.O shape ring 300 and 302 is arranged to seat and puts on piston 226 to provide leakproof seal and to prevent from external contaminants from entering piston chamber.Bottom 280 also comprises fluid passage 304, and it is for the formation of the fluid conduit systems shown in Figure 10.Finally, spring 306 and 308 is arranged to spring load actuation button 216 and 218.

Intermediate layer 282 is formed by flexible film material.The part 296 in intermediate layer is contained in reservoir part 286 to form reservoir 222 (Figure 10).Rigid plate 310 is arranged to the part 296 adhering to reservoir.Because layer 282 is flexible membrane, therefore it will move when filling and emptying reservoir.Then rigid plate 310 will move thereupon.Described plate comprises the eyelet 312 that size is configured to receive elongated web 314 size, and this elongated web forms a part for levels of drugs indicator hereinafter described.Web 314 carries indicatrix or feature structure 316.

Top layer 284 to be positioned to receive on intermediate layer 282 and to adhere to bottom.It comprises the panel 320 with form 318, by form 318 observable levels of drugs indicatrix.

Finally in conjunction with Figure 12, can point out, device 210 also comprises pin 322.Pin 322 is lock pin, and it is for sending the finger lock actuation button of last drug dose.It also for maintaining blocked state by the filling mouth (will be described below) of device after sending last drug dose.

Referring now to Figure 14 and 15, Figure 14 and 15, be the perspective profilograph of the device of Fig. 9, described device has the cannula assembly can installed in a device.Figure 14 illustrates the aforementioned hierarchy of device 210, comprises device layers 280,282 and 284.Also can point out from Figure 14, described device comprises the port for holding cannula assembly 340.Cannula assembly has base 342, the docking structure 344 of general cylindrical and intubate 346.Docking structure 344 is arranged to cannula assembly 340 is being applied to patient skin and intubate is held by port 330 (Figure 15) during projection below patient skin.Described device comprises the pin 348 of the barrier film 350 protruding through device when cannula assembly 340 is held by port 330.This accomplishes the fluid passage from reservoir 222 to intubate 346.About this type of cannula assembly and the more detailed description of device using same cannula assembly, the name can submitted to reference to May 11 in 2007 is called the U.S. Patent Application Serial Number 11/803 of the CO-PENDING of " INFUSIONASSEMBLY ", 007, this application is all and be incorporated herein by reference by this assignee.

Figure 14 and 15 is also clearly shown that and embodies levels of drugs indicator of the present invention.Rigid plate 310 is formed along with medication amount increase in reservoir and reduces and the displaceable wall of movement.Elongated web 316 is preferably formed by non-resilient, incompressible elongated material.It has first end 352 and the second end 354.Described web is fixed on first end 352 place relative to the rigid plate 310 of reservoir 222, and is arranged to move in the first roughly vertical with rigid plate 310 plane, and wherein rigid plate 310 is positioned in the middle of first end 352 and the second end 354.Because web 316 is fixed on first end 352 place and moves freely in eyelet 312, therefore, its second end 354 by substantially parallel with rigid member and with the second plane of the first flat transverse in move in Linear-moving mode.

As previously mentioned, the panel 320 of top layer 284 has window opening 318 to make levels of drugs instruction visible.Cover plate 320 forms guiding channel 356, and this guiding channel holds and defines web the second end and move to guide the second plane neutral line that web is extending substantially transversely to the first plane.When filling or emptying reservoir, pan window 318 will provide the instruction of reservoir 222 Chinese medicine level.

Referring now to Figure 16, it is sectional plain-view drawing, illustrates that the valve constitution of the device 210 of period Fig. 9 filled by pump chamber 228 medicine soon after dose is sent.Clearly visible at this, the first actuation button 216 has the extension of the bar 241 that shuttles back and forth comprising valve 232 and 234.Be positioned at above valve is to the conduit of intubate from reservoir to intubate, from pump.More specifically, conduit 242 is communicated with reservoir 222 (Figure 10) fluid, and conduit 244 is communicated with pump fluid, conduit 246 and slotting fluid communication.Described valve is shown as the first valve 232 and opens and do not block reservoir conduit 242, and the second valve 234 cuts out and blocks the conduit 246 to intubate.When actuation button 216 is back to its primary importance, this allows medicine to be flowed out from reservoir by conduit 242, and arrives pump chamber 228 by conduit 244.Therefore, pump chamber is filled and sends ready for subsequent dose.

Referring now to Figure 17, it is the sectional plain-view drawing of the valve constitution of the device 210 illustrated at drug delivery period Fig. 9.Here, described valve is shown as the first valve 232 and cuts out and block reservoir conduit 242, and the second valve 234 is opened thus allowed medicine to be flowed out from pump by conduit 244, and arrives intubate by conduit 246.As previously mentioned, the first valve 232 and the second valve 234 separate respectively, make occlusion catheter 242 before opening conduit 246.

Figure 18-22 illustrates the details of the operation of the second connector 254 of device 210.Run through this discussion, may need simultaneously with reference to more than one accompanying drawing.Can as shown in figure 18, the first actuation button 216 has extension 380, and this extension ends at the block 382 with the first ramped surfaces 384 and the second ramped surfaces 386.When actuating device 210, button 216 and pump button 218 are pressed simultaneously.Button and extension 380 thereof and block 382 freely move to right.As shown in Figure 18 and 21, pump actuation button 218 has parallel extensions 400 and 402, and they connect and separate for rod member 404.As shown in figure 18, extension 400 adjoins bearing 388, must be clear that bearing 388 can move to left.As shown in figure 21, when button 216 is pressed, its extension 380 moves to right and causes the first ramped surfaces to engage with rod member 404.Button continues to move causes rod member 404 to rise under the first ramped surfaces 384, and this causes extension 400 start slightly to move to left and be bent upwards around rib 405 then.Finally, rod member 404 upwards arches upward the length on the first slope 384, causes the end 401 of extension 400 to shift out bearing 388, as shown in figure 19.Present pump button 216 can freely move to left.When the end 401 of extension 400 shifts out bearing 388 completely, it will be fastened on bearing 388 below and become and be temporarily lockable as shown in figure 20.Meanwhile, as shown in figure 22, rod member 404 has been passed down through the second ramped surfaces 386.Button 216 and 218 is fully pressed now.

Therefore originally pump button 218 can not move freely, and the first actuation button 216 of driven valve can move freely therefore.As a result, pump activates and lags behind valve and activate, and causes the first valve 232 (Figure 10) to be closed and the second valve 234 is opened, thus can start pump at pump and inhale the drug delivery flow channel set up before medicine to patient and lead to intubate.Because this operation occurs very fast, therefore two actuation buttons patient are seemed to move with identical speed.

When the extension 400 of pump button shifts out bearing 388, it becomes and is lockable in snap action.The same with preceding embodiment, the positive feedback that this medicine providing dose to patient has been sent as required.This also causes a complete dosage to be delivered.By the snap action of pump actuator, only all dosage can be taken.

When medicine is sent, the spring load of actuation button button is back to its first or initial position.In the meantime, the identical timing that provides of block 382 is for recharging pump.More specifically, slope 386 discharges the end 401 of extension 400 by lifting rod member 404, to close 246 and open conduit 242 before pump is back to its initial position by spring.Which ensure that pump only can not extract medicine from patient from reservoir.When the piston 226 of piston pump 224 returns, an all dosage medicine is drawn into piston chamber 228 and thinks that the subsequent dose of device is sent ready.

Figure 23 and 24 illustrates the operation of piston pump 224 in further detail.Also the final dose locking 420 that will be described below is shown.Can find out, the piston 226 of pump 224 is the extension of pump actuation button 218 herein.Also can find out, O shape ring 300 and 302 packed-piston 226 and room 228.Two O shape rings all prevent medicine from revealing from room 228, and prevent from external contaminants from entering room 228.

Along with actuation button to be back to shown in Figure 23 first or initial position from the second position shown in Figure 24 after dose delivery, when pump chamber filled drug, medicine flows out from reservoir, through conduit 307 (Figure 13), arrives pump chamber 228 through chamber of septum 424 and through conduit 244.Room 424 is limited by barrier film 422, and this barrier film is formed by flexible film material.Barrier film 422 comprises and captures the extension of pin 322, as shown in the exploded view of Figure 12 above.As long as have medicine in reservoir, and be not therefore empty, barrier film 422 is just unaffected.In this state, button 216 freely activates.

It is pointed out that end 323 place that described pin has a L shape extension 428 is L shape.Capture slope 430 near pin 322 with actuation button all-in-one-piece, and be positioned at above L shape extension 328.As long as this occur in reservoir have enough medicines with at least one or more dose delivery is provided and actuation button is pressed time.

When describing the operation of final dose locking 420, may need now with reference to Figure 25 and 26.When the medicine in reservoir is not enough to support another dosage drug delivery, and after so-called final dose is sent between actuation button 218 return period, in chamber of septum 424, produce negative pressure.This causes barrier film 422 to be sucked up in room 424 owing to lacking fluid medicine in room 424.When barrier film 422 is sucked up to room 424, pin 322 is pulled up along with barrier film 422, and it engages with the bearing 432 being connected to slope extension 430 herein.Present pin 322 is crawled between slope 430 and bearing 432.Button 216 is only partly back to its primary importance now, and pump actuation button 218 is back to its initial position freely completely.Upper once attempt actuating device after, L shape extension will arch upward slope 430 and the latched position fallen between slope 430 and shoulder 434, and described shoulder is formed in actuation button 216.Button pins now, can not be back to its primary importance.Pump actuation button 218 also will be locked in its second position as shown in figure 26.This is the fact because the first button 216 can not return from its second position (as shown in figure 20), causes the end 401 of the extension 400 of pump actuator 218 to be locked between bearing 388 and actuation button 216.Therefore, device 210 is lockable now, can not re-use.

Referring now to Figure 27 and 28, Figure 27 and 28, the other aspect that final dose locks is shown.Before device 210 can use with delivering drugs, its reservoir must filled drug.For this reason, device 210 provides the filling mouth 440 be communicated with reservoir.When device 210 filled drug, actuation button 216 and 218 is in its initial position.First actuation button 216 also comprises another extension 442, and when actuation button 216 is at its initial position, extension 442 does not cover and fills mouth 440.But when actuation button 216 is in the second position that it activates completely, its blocks filling mouth 440 as shown in figure 28 really.When final dose lock locking device time, actuation button 216 is left on its second position activated completely.As a result, final dose locking has not only pinned both actuation buttons 216 and 218 with forbidden device 210, and it also blocks fills mouth 440 with further forbidden device.

Referring now to Figure 29, it illustrates an embodiment of drug delivery system, and wherein medical injection device 500 comprises " durable " parts 500 and " disposable " parts 600.This embodiment of the present invention relates to so a kind of system, and described system is used for sending medical injection device that is basic and medicine before the meal.In addition, this embodiment adopts a kind of parts, and described parts have reciprocable machine, power supply and electronic control system at least one exemplary embodiment, to allow automatic, able to programme and/or computerized infusion of medicine.

Suffers from some needs of patients continuous subcutaneous insulin injection all day of such as type 1 diabetes etc., to compensate pancreatic function.For these patients, the medical injected system adopting the basal insulin can sent except pre-meal insulin may be it is desirable to.For this reason, provide complete function, computerization, programmable insulin pump for many years always.Exemplary insulin pump in these insulin pumps is the insulin pump that AnimasCorporationofWestChester, Pennsylvania (USA) sell, such as OneTouch ^tMping and Animas2020 ^tM.The exemplary description of this type of insulin pump is found in United States Patent (USP) 6,656,148, and this full patent texts is incorporated herein by reference accordingly.

Although comprehensive, the computerized insulin pump of some Finding case using function is useful, but at investment several thousand dollars before computerization drug delivery system, most diabetics begins through syringe and carries out repeatedly insulin injection every day, then more convenient or automatic delivery system is turned to, such as can wear infusion of medicine system, as shown in figures 1-28.For than the special device sent for pre-meal insulin and computerization insulin delivery system (this type of middle device as shown in figure 29), there is multi-purpose system, may intermediate steps be there is in patient disease management.

The medical injected system of Figure 29 comprises to wear on skin until the disposable unit 600 that exhausts of fluid reservoirs 510.During this period, durable components 550 is connected to disposable unit 600, provides the mechanism for being inhaled medicine from reservoir 510 by intubate 540 pump, under intubate 540 is embedded in patient skin.When reservoir exhausts, durable components 550 and disposable unit 600 disconnect and retain.Disposable unit 600 is removed from patient and abandons.Then, the new disposable unit comprising full reservoir medicine is arranged on patient skin, durable components 550 is connected to the new disposable unit installed.

Medical injected system as shown in figure 29 comprises the disposable unit 600 with multi-ply construction.Disposable unit 600 is configured to be arranged on patient skin, and uses the adhesive patch 505 installed on the downside of shell 501 that it is adhered thereto removedly.Shell 501 comprises reservoir 510, for a certain amount of medicine of splendid attire.Reservoir 510 is supplied to patient after can being pre-charged with maybe will have and fill mouth (not shown) and fill reservoir 510 before use to allow patient.Filling mouth structure can comprise these structures aforesaid herein maybe can comprise self-sealing septum, can insert that medicine is introduced reservoir 510 by this barrier film hypodermic needle.Reservoir can be discharged to assist filling process, or by the user or medical personnel instructing completion system preparation before use, gas be removed from system.

Reservoir 510 is communicated with pump chamber 532 fluid.Pump chamber is by the pair of check valves 530 being arranged to pumping fluid stream, and 530 ' holds.By fluid being sucked pump chamber 532 to outdoor contraction flexible membrane 525, when flexible membrane 525 is forced to inwardly enter pump chamber 532, fluid is discharged then.The fluid of discharging is introduced in patient body by intubate 540.

The embodiment of the present invention shown in Figure 29 depicts and manufactures cheap disposable unit 600.These parts are manufactured by following material by injection mo(u)lding or additive method known in the art, and described material includes but not limited to Polycarbonate plastics, ABS or TOPAS ^tMcyclic olefine copolymer (being sold by TOPASAdvancedPolymers, Inc.ofFlorence, Kentucky).Such as TOPAS ^tMadvantage Deng material is it is the transparent polymer of primitive form, and allow it to be used to the objects such as such as fluid reservoirs, in fluid reservoirs, transparent material can allow device user to check reservoir remains with how many contents in preset time.Being intended to disposable parts usually can by not comprising such as TOPAS ^tMthe material manufacture of the Polychlorinated biphenyls (PCB) of (due to environmental protection cause) etc.

The most common version of durable components 550 as shown in figure 29.Durable components comprises at least for making the reciprocating motor 560 of flexible membrane 525 and circuit for controlling motor 570 and power supply 580.Motor 560 is configured to movement actuator 565 in complex way.Actuator 565 push-and-pull flexible membrane 525 moves to form fluid in pump chamber 532.

Power supply 580 depends on whether durable components with the addition of interval needed for additional function, motor size etc. and battery altering.Usually, power supply 580 will comprise one or more button battery (such as: CR2032 and similar battery), AA, AAA, N or 9V battery.The feature structure that durable components can comprise comprises microprocessor and the memorizer for the drug delivery agreement that stores pre-programmed.Little and example that the is processor that energy consumption is low comprises TexasInstrumentsMPS430.Depend on and comprise how many RAM, can store multiple drug delivery agreement, user can use small keyboard input device and display screen (not shown) to select it, edit or add.In order to minimize the cost of durable components 550, these parts can comprise communication function to send and to receive the data from remote-control device, such as computer, handheld remote control device, smart mobile phone etc.Data transmission can use RF, IR or other wireless forms of communication known in the art.Alternatively, durable components can be configured to have one or more port, and described one or more port allows to use such as USB, live wire (IEEE-1394 and modification), RS-232 serial communication etc. to be physically connected to remote-control device.In this type of embodiment, user durable components 550 can be connected to be furnished with microprocessor device to programme to it, data download, historical record, daily record etc., and/or upload drug delivery agreement.Even if durable components 550 also can comprise removing, close, exhaust installation's power source after the simple displaying device (not shown) of also misdirection state, warning or other important informations.The exemplary display of these display is bistable display, as United States Patent (USP) 8, and 310, described in 415, this full patent texts is incorporated herein by reference accordingly.

Electronic-controlled installation 570 controls machine operation cycle, speed etc. by being usually configured to.When using plate carry microcontroller or microprocessor and the drug delivery agreement of programming be stored in RAM or ROM used together with microprocessor or microcontroller, clocking capability can be performed by crystal oscillator on sheet or timing chip (such as, 555 timer chips).Alternatively, crystal oscillator or timer chip can be added into electronic-controlled installation 570.

Figure 30 illustrates an embodiment of disposable unit 600 of the present invention.How the hierarchy and the reservoir 510 that show these parts are formed.Base 605 is configured with the barrier film 610 that can be used for filling reservoir 510 and the aperture 660 creating fluid passage by it.The ground floor of base 605 should comprise framework 625, and this framework has the adapter of fluid line.Succeeding layer should comprise the upper casing 630 of reservoir.Preferably, upper casing 630 comprises the transparent materials such as such as transparent polymer film, to allow the content checking reservoir 510.Connect these layers by any mode as herein described or method, but usually will pass through ultrasonic bonding, laser weld or chemical adhesion (such as, binding agent) and make it for good and all be attached to one another.

The device of Figure 31 illustrates base and the reservoir configurations of Figure 30, and the structure of exemplary fluid channels is shown.Check-valves 626 is shown as and reservoir 510 is connected to the room shell 632 with flexible membrane 625 by framework 620, and the inside of room shell 632 defines pump chamber 532.The outlet of room shell 632 is connected to the second check-valves 626 '.As Figure 32 further shown in, check-valves 626 ' completes fluid line by conduit 627 through aperture 660, and conduit 627 ends at the intubate 665 be configured to insert under patient skin.Figure 33 a illustrates the device of the Figure 32 with the cap 675 illustrated with decomposed, and Figure 33 b illustrates the perspective view of the device of Figure 33 a.Cap 675 is that the installed surface of disposable unit and durable components 550 provides protection.

Figure 34 also illustrates the drug delivery system of Figure 33 a, the 33b with cap 675, and cap 675 is configured with the sliding rail 710 for holding durable components shell 700.Figure 35 a further depict durable components shell 700.Durable components shell 700 comprises shell 705, and shell 705 has guide rail 715 and is attached to disposable unit 600 slidably and removably to allow durable components shell 700.Although show track and guide rail, those skilled in the art will recognize that to there is the method and structure that durable components 700 is removably attached to disposable unit 600 by multiple permission.As further shown, durable components 700 comprises motor driver 720, and motor driver 720 adopts and rotates to make the reciprocating cam mechanism (not shown) of actuator 725.As Figure 35 b further shown in, durable components 700 can comprise electronic controller 735 and power supply 730 (with illustrative and non-limiting way depicts button cell).Figure 36 illustrates that, according to device of the present invention, wherein durable components 700 is removably attached to disposable unit 600.

Although illustrate and describe specific embodiments of the invention, also can modify to embodiments of the invention.Such as, except manual activation valve used herein and load on spring return valve, the structure completed by opposite way that is spring-actuated and that manually return may be there is.Therefore, be intended to contain in appended claims all this type of and meet change as the true spirit of the present invention in these claim and scope and amendment.

Claims

1. a drug injecting device, comprising:

Disposable unit, described disposable unit comprises:

The reservoir of splendid attire fluid medicine;

At least one valve that the medicine be moved is derived from reservoir;

Fluid passage, described reservoir is originated from described fluid passage, comprises pump chamber, and ends at the intubate being arranged to subcutaneous insertion; And

Durable components, described durable components comprises:

Motor, electric machine controller and power supply;

Wherein said disposable unit comprises the hierarchy limiting described reservoir and fluid conduit systems.

2. device according to claim 1, wherein said disposable unit comprises hierarchy, and described hierarchy comprises bottom, overlies the intermediate layer of described bottom and overlies the top layer in described intermediate layer.

3. device according to claim 2, wherein said bottom comprises the binding agent for described device being adhered to patient skin.

4. device according to claim 2, wherein said bottom and intermediate layer form described reservoir.

5. device according to claim 2, wherein said pump chamber comprises flexible membrane, and wherein said pump chamber is formed in described bottom.

6. device according to claim 2, wherein said valve comprises more than one check-valves and is formed at least in part in described bottom.

7. device according to claim 2, wherein said durable components comprises the one or both in microprocessor and random access memory and read only memory.

8. device according to claim 7, wherein microprocessor stores one or more drug delivery agreement.

9. device according to claim 7, wherein said microprocessor is arranged to and communicates with remote-control device.

10. device according to claim 9, it is one or more that wherein said remote-control device comprises in computer, smart mobile phone and handheld remote controller.

11. devices according to claim 9, wherein said microprocessor is configured to use radio frequency protocol to communicate with described remote-control device.

12. devices according to claim 9, wherein said durable components comprises bistable display.

13. devices according to claim 2, wherein said durable components is removably attached to described disposable unit.

14. devices according to claim 2, wherein said durable components comprises one or more guide rail, and described disposable unit comprises one or more track, and described durable components is attached to described disposable unit slidably.

15. devices according to claim 14, at least one deck in wherein said disposable unit is manufactured by cyclic olefine copolymer.

16. devices according to claim 15, wherein said disposable unit is by the material manufacture being substantially free of polybiphenyl.